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Regulatory Information Management

Different countries enforce different regulations and standards, making regulatory information management (RIM) the biggest challenge for regulatory affairs, submissions, and quality professionals in life science companies. The requirements are just dissimilar enough from market to market to create confusion and accumulate massive documentation.

MasterControl Regulatory Excellence, a cloud-based RIM solution, integrates content management with registration and submission capabilities to simplify global submissions and accelerate time to market.

Benefits of a Regulatory Information Management

Provide your regulatory and submission personnel with the essential tools for content collection, dossier management, and document lifecycle management on a single platform.

  • Efficient RIM: Improve efficiency by automating the collection and management of regulatory content and data, including design concepts, prototypes, and design and technical files.
  • Increased Collaboration: Harmonize regulatory and quality processes for better collaboration between the teams managing those processes and increased productivity.
  • Streamlined Global Submissions: If you are registering products in multiple countries, management of dossier and technical documents will be easier with the help of a global checklist template designed to mirror regulatory pathways.
  • Centralized Platform: Centralize content and data under one platform for a single source of truth accessible to all stakeholders regardless of geographic location.
  • Continuous Project Management: An automated RIM system provides continuous monitoring and updates of every registration project, from start to finish.
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Results of Good Regulatory Information Management

To successfully introduce your medical devices, medicines, and other regulated products worldwide, you need a RIM system that will help ensure regulatory compliance and product quality and increase efficiency to accelerate time to market.

A robust electronic RIM system is crucial to help you attain the following:

A Single Source of Truth:
An automated system will ensure that users across the globe will be using current, approved documentation because they will be pulling it from the same centralized source.

Transparency of Processes:
The visibility of product registration projects is crucial for companies making submissions for multiple products and markets. An electronic system provides transparency and the capability to track documents, tasks, and deadlines in a way that a manual system never could.

Simplify Granularity of Global Regulations:
Every country or region has its own requirements for different regulated products. While there are many similarities using the same product information, there are also distinct nuances. An automated RIM system can help simplify the workflow and users’ tasks despite the granularity of regulations.

Connected Processes:
It’s common for companies to invest in multiple systems that can’t “talk” to each other, which means the teams running those systems can’t work together efficiently either. An integrated RIM would be able to connect different processes and their users.

Standardized Filings:
Many companies who cling to a paper-based system end up with inconsistent submission filings, which are prone to errors and noncompliance. An automated system can standardize submissions with templates and ensure consistent filings across geographic locations.

How MasterControl Regulatory Excellence Can Help You

MasterControl will provide your organization with a robust and scalable RIM system to help you launch medical devices, pharmaceuticals, or other regulated products throughout the world. The system will equip your users with the right tools to meet the registration and submission challenges of the global market head on.

Automated Platform:
Instead of keeping massive regulatory information in electronic servers or hard copy, automate your RIM system to increase efficiency and improve your control and tracking of documents and timelines.

Streamlined Submissions:
Through automation, MasterControl simplifies the compilation, routing, review and approval of content. Submission planning will be integrated with full document lifecycle management for a more efficient workflow.

Timely Submissions:
MasterControl will help you track down any changes in projects, flag down any delays and bottlenecks, and alert users to upcoming registration expirations or deadlines. It will give you the agility to respond to issues in a timely manner for on-schedule submissions.

Ensure Compliance Before Submission:
Many companies outsource the actual submission process to a vendor or export their dossier to another system for submission. With MasterControl, you can generate, manage, and finalize all content to ensure compliance before doing either one.

Powerful Reporting:
Improve portfolio and project planning with MasterControl’s powerful analytics and reporting tools. Regular reports will help you anticipate trends and plan for future product iterations.

Robust Lifecycle Management:
MasterControl empowers users to achieve process excellence throughout the product development lifecycle with the right tools on a single platform.

Learn More about MasterControl Regulatory Excellence

For more information about MasterControl’s solutions for regulatory professionals, contact a MasterControl representative today.